TARGETSCAN BIOPSY KIT— 510(k) K041638

Unknown

Envisioneering, LLC

FDA 510(k) clearance K041638 for TARGETSCAN BIOPSY KIT, Unknown on 2004-09-02. Applicant: Envisioneering, LLC.

Clearance details

Applicant: Envisioneering, LLC
Product code: Code ITX
Advisory panel: Radiology
Date received: 2004-06-17
Decision date: 2004-09-02
Decision: Unknown
Clearance type: Traditional
Location: St. Louis, MO, US

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Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.